Tina-quant Hemoglobin A1cDx Gen.3
FDA 510(k) K193053 · Roche Diagnostics Operations (Rdo)
510(k) numberK193053
Submission
- Device name
- Tina-quant Hemoglobin A1cDx Gen.3
- Applicant
- Roche Diagnostics Operations (Rdo)
Indianapolis, IN, US - Received
- November 1, 2019
- Decision date
- March 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDJ – Hemoglobin A1c Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1373
- Specialty
- Clinical Chemistry
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Other 510(k)s with product code PDJ
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|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test SystemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 01/06/2026SE |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | Tosoh Bioscience, Inc. | 10/03/2025SE |
| K242911 | Medconn Glycated Hemoglobin Test systemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 06/20/2025SE |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test SystemPDJ · Traditional | Shijiazhuang Hipro Biotechnology Co., Ltd. | 09/12/2024SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | Tosoh Bioscience, Inc. | 08/05/2021SE |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssayPDJ · Special | Siemens Healthcare Diagnostics, Inc. | 07/02/2021SE |
| K182651 | HbA1c AdvancedPDJ · Traditional | Beckman Coulter Ireland, Inc. | 01/16/2019SE |
| K182988 | Afinion HbA1c Dx on Afinion 2PDJ · Special | Alere Technologies AS | 11/29/2018SE |
| K173909 | Dimension Hemoglobin A1c AssayPDJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2018SE |
| K173206 | SEKURE HbA1c AssayPDJ · Traditional | Sekisui Diagnostics P.E.I., Inc. | 07/12/2018SE |
More from Sekisui Diagnostics P.E.I., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192072 | Tina-quant C-Reactive Protein IVDCN · Traditional | 02/21/2020SE |
| K183517 | Ammonia IIJIF · Traditional | 02/08/2019SE |
| K182095 | Tina-quant Transferrin ver.2 (urine application)DDG · Traditional | 11/05/2018SE |
| K171080 | ALP IFCC Gen.2CJE · Special | 05/10/2017SE |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJ · Traditional | 12/19/2016SE |
| K162593 | HDL-Cholesterol Gen.4LBS · Traditional | 10/19/2016SE |
| K161817 | Tina-quant Cystatin C Gen.2NDY · Special | 07/27/2016SE |
| K160570 | Creatine KinaseJHS · Traditional | 05/25/2016SE |
| K152245 | ONLINE TDM Vancomycin Gen.3LEH · Traditional | 01/08/2016SE |
| K151578 | Carbamazepine Gen 4KLT · Traditional | 10/22/2015SE |
Questions and answers
When was Tina-quant Hemoglobin A1cDx Gen.3 cleared by the FDA?
Tina-quant Hemoglobin A1cDx Gen.3 (K193053) received a 510(k) decision of Substantially Equivalent on March 26, 2020, 146 days after the submission was received.
What is the product code of K193053?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.